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FDA 510(k) Application Details - K021430
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device
510(K) Number
K021430
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
ROLOR ELECTRONICS CORP.
NO. 58 FU-CHIUN ST.
HSIN-CHU CITY TW
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Contact
Ke-Min Jen
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
GZJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/03/2002
Decision Date
12/02/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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